Pharmaceutical products having abuse potential include narcotics, sedatives, stimulants and drugs from other categories. Of particular concern are narcotics, for which abuse-deterrent formulations have been developed using a variety of techniques. Most of these techniques aim to prevent alternative routes of administration for a prescribed drug, typically an oral product. The vast majority of such formulations have been solid dosage forms, and techniques have been developed to render such forms difficult to crush, extract using common household solvents, snort or inject due to physical characteristics. One common approach, for example, is to add an antagonist or other objectionable component that is sequestered from the beneficial drug, and remains sequestered in use unless the dosage form is manipulated, rendering the drug ineffective or undesirable. Examples of this include buprenorphine/naloxone combination (Suboxone, Reckitt Benckiser) and morphine/naltrexone (Embeda, King Pharmaceuticals); This basic approach, however, has severe limitations for some formulations such as liquids. For these, ion-exchange resins have been employed to limit release of the drug, inhibiting manipulation of the product to achieve a faster onset. An example of this is methylphenidate extended release (Quillivant XR, NextWave Pharma). For some drugs having very high therapeutic dose for a drug which require immediate release, such as sodium oxybate, use of resins is limited both by convenience of dosing a large amount of resin and also associated toxicological concerns.
There are other modes of abuse or misuse not addressed by existing methods of abuse deterrence. These are accidental misuse, intentional misuse for therapeutic benefit, surreptitious administration to others, and theft or diversion for unauthorized use. These are modes that do not necessarily apply to discrete dosage forms, such as tablets, pills, or capsules that can be counted and are difficult to take in partial increments, difficult to give to others accidentally or intentionally, and difficult to surreptitiously administer. For an oral solution, however, there are limited means of providing protection and assurance against any use other than prescribed.
Thus, there exists a need for providing devices, methods and formulations that protects against accidental use, diversion or misuse and also compliance to dosing instructions.